The Disposable Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Disposable Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

Device Description

Disposable Surgical Mask, Ear Loop Type, Size M and S is a single use, three-layer, flat-pleated mask with ear loops and a nose piece. The Disposable Surgical Mask is manufactured with three layers, of which the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The latex free elastic ear loops are made of polyamide fibers and spandex. The nose piece in the layers of face mask allows the user to fit the face mask around their nose, which is made of core iron wire with halogen-free polyethylene covering. The Disposable Surgical Mask will be provided in blue of outside and white of inside. The Disposable Surgical Mask is provided non-sterile and for single use.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a Disposable Surgical Mask (K212944). It describes the device, its intended use, and a comparison with a predicate device, along with non-clinical test results.

However, the questions you've asked are typically relevant to the validation of Artificial Intelligence (AI)/Machine Learning (ML) medical devices, particularly those that involve image analysis, diagnosis, or risk prediction. This document is for a physical medical device (surgical mask) and the submitted information pertains to its physical performance characteristics, not its performance in an AI/ML context.

Therefore, many of your specific questions, such as those related to:

Ground truth establishment by experts
Adjudication methods
Multi-reader multi-case (MRMC) studies
Standalone algorithm performance
Training set size and ground truth establishment

are not applicable to the context of this 510(k) submission for a surgical mask. The document does not involve AI/ML.

I can, however, extract the relevant information regarding the acceptance criteria and the study that proves the device meets those criteria for the surgical mask, based on the provided text.

Acceptance Criteria and Device Performance for Disposable Surgical Mask (K212944)

The device in question is a Disposable Surgical Mask, and its performance is evaluated against established physical and biological standards for medical masks.

Here's a summary tailored to the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Test Method	Acceptance Criteria	Reported Device Performance	Result
Fluid Resistance Performance	ASTM F1862	29 out of 32 pass at 120 mmHg	31 out of 32 pass at 120 mmHg	Pass
Particulate Filtration Efficiency	ASTM F2299	≥ 98%	99.7%	Pass
Bacterial Filtration Efficiency	ASTM F2101	≥ 98%	99.5%	Pass
Differential Pressure (Delta-P)	MIL-M-36954C	< 6.0 mmH2O/cm²	4.24 mmH2O/cm²	Pass
Flammability Class	16 CFR 1610	Class 1	Class 1	Pass
Biocompatibility (Cytotoxicity)	N/A	Non-cytotoxic	Proposed device extract non-cytotoxic	Same
Biocompatibility (Irritation)	N/A	Non-irritating	Proposed device non-irritating	Same
Biocompatibility (Sensitization)	N/A	Non-sensitizing	Proposed device non-sensitizing	Same

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Physical Performance Tests:
- Fluid Resistance (ASTM F1862): 32 samples were tested to achieve the acceptance criteria of "29 out of 32 pass". The reported performance was "31 out of 32 pass".
- For other tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability Class), the specific number of samples tested is not explicitly stated, but the results are reported as single values (percentages, pressure, or class), implying multiple samples were likely tested to obtain representative values for product conformance.
Data Provenance: Not explicitly stated regarding the origin of the testing data itself (e.g., country of origin of the samples). However, the manufacturer is in Heilongjiang, China. The tests were performed in accordance with ASTM and MIL standards, which are international standards. The study is a non-clinical test to demonstrate device performance against established standards. It is analogous to a prospective study in the sense that the device was manufactured and then tested to these specific criteria.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable. This is a physical medical device (surgical mask), not an AI/ML diagnostic or predictive device. "Ground truth" in this context refers to the measured physical characteristics (e.g., filtration efficiency, fluid resistance) as determined by standardized laboratory testing methods, not by expert interpretation of images or patient data. The expertise lies in performing and interpreting these specific laboratory tests according to the cited ASTM and MIL standards.

4. Adjudication Method for the Test Set

Not Applicable. As per point 3, there is no expert adjudication for the objective physical and biological performance tests of a surgical mask. Results are based on quantitative measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study is relevant for AI/ML devices where human readers (e.g., radiologists) use the AI to improve their performance. This 510(k) is for a physical surgical mask and does not involve AI assistance for human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not Applicable. There is no algorithm or AI component to this medical device.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on objective, standardized laboratory measurements of its physical properties (e.g., fluid resistance, filtration efficiency, differential pressure, flammability) and biocompatibility (cytotoxicity, irritation, sensitization). These are determined by adhering to specified test methods from organizations like ASTM and MIL.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML device, so there is no "training set" in the machine learning sense. The device is manufactured based on design specifications and then tested to verify its performance.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As per point 8, there is no training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 15, 2021

Heilongjiang Yinjia Medical Equipment Co., Ltd. % Doris Dong Manager Shanghai CV Technology Co., Ltd. Room 903, No.19 Dongbao Road, Songjiang Area Shanghai, Shanghai 201613 China

Re: K212944

Trade/Device Name: Disposable Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 2, 2021 Received: September 13, 2021

Dear Doris Dong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212944

Device Name Disposable Surgical Mask

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary [As required by 21 CFR 807.92]

1. Submission Information:
510(k) Number:	K212944
Date:	December 15, 2021
Type of 510(k) Submission:	Traditional
Basis for 510(k) Submission:	New device
Applicant/Manufacturer:	Heilongjiang Yinjia Medical Equipment Co., Ltd.
	F3-4, Plant 6, No.10, Hanan 12th Road, Nangang District, Harbin City
	Heilongjiang, China 150000
Contact person:	Doris Dong
	[Consultant, from Shanghai CV Technology Co., Ltd.]
	Add: Room 903, No. 19 Dongbao Road, Songjiang Area, Shanghai, 201613 China
	E-mail: doris.d@ceve.org.cn
	Tel: 86 21-31261348 / Fax: 86 21-57712250

2. Device Description:

Proprietary Name:	Disposable Surgical Mas
Model	Size M, Size S
Common Name:	Surgical mask
Classification Name:	Mask, Surgical
Regulation Number:	878.4040
Product Code:	FXX
Device Class:	II
Review Panel:	General Hospital

3. Predicatedevice

Surgical Face Mask, K182515

WUHAN DYMEX HEALTHCARE CO., LTD

This predicate has not been subject to a design-related recall. No reference devices were used in this submission.

4. Device Description

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5. Intended Use/Indication for use

6. Technological Characteristics Comparison with the predicate device:

Table 1 General comparison

Device	Proposed device	Predicate device	Comparison
510(k) Holder	Heilongjiang Yinjia MedicalEquipment Co., LTD	WUHAN DYMEXHEALTHCARE CO., LTD	--
510(k) Number	K212944	K182515	--
Name	Disposable Surgical Mask	Surgical Face Mask	--
Model	Size M, Size S	/	--
Classification	Class II Device, FXX (21 CFR878.4040)	Class II Device, FXX (21 CFR878.4040)	Same
Intended use/Indicationsfor Use	The Disposable Surgical Mask isintended to be worn to protectboth the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluids andparticulate material. TheDisposable Surgical Mask isintended for use in infectioncontrol practices to reduce thepotential exposure to blood andbody fluids. This is a single use,disposable device(s), providednon-sterile.	The Surgical Face Masks areintended to be worn to protectboth the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluidsand particulate material. Theseface masks are intended for usein infection control practices toreduce the potential exposureto blood and body fluids. Thisis a single use, disposabledevice(s), providednon-sterile.	Same
Mask style	Flat Pleated	Flat Pleated	Same
Design	Ear loop	Ear loop	Same
Layers	Three	Three	Same
Dimension	Size M: 17595mmSize S: 14095mm	175*95mm	SimilarNote 1
Color	Blue outside; white inside	Yellow	DifferentNote 2
Sterility	Non-sterile	Non-sterile	Same
Target population	Adults	Adults	Same
Use	Single use, disposable	Single use, disposable	Same
Anatomical site	Nose and mouth	Nose and mouth	Same
Technology	Self-suction filter mask	Self-suction filter mask	Same
Environment ofuse	OTC	OTC	Same
Material
Outer facing layer	Spunbond polypropylene	Spunbond polypropylene	Same
Middle layer	Melt blown polypropylene filter	Melt blown polypropylene filter	Same
Inner facing layer	Spunbond polypropylene	Spunbond polypropylene	Same
Ear loops	Polyamide fibers, Spandex	Spandex	Same Note 2
Nose piece	Core iron wire with polyethylenecovering	Malleable polyethylene wire
Colorants	Polypropylene (PP) master batch	Unknown
ASTM F2100	Level 2	Level 2	Same
Level
Biocompatibility (limited contact (<24h) surface devices on intact skin)
Cytotoxicity	Under the conditions of thestudy, the proposed deviceextract was determined to benon-cytotoxic.	Under the conditions of thestudy, the predicate deviceextract was determined to benon-cytotoxic.	Same
Irritation	Under the conditions of thestudy, the proposed device non-polar and polar extracts weredetermined to benon-irritating.	Under the conditions of thestudy, the predicate devicenon-polar and polar extractswere determined to benon-irritating.	Same
Sensitization	Under the conditions of thestudy, the proposed device non-polar and polar extracts weredetermined to benon-sensitizing.	Under the conditions of thestudy, the predicate devicenon-polar and polar extractswere determined to benon-sensitizing.	Same

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Differences between New device and Predicate Device:

Note 1:

The proposed device has two sizes while the predicate device only has one size. Because the physical performance tests and Biocompatibility tests results of mask depend on the materials and manufacturing process not the size. Furthermore, there is no difference between the two models except for the size.

Note 2:

Biocompatibility evaluation has been performed on the finished device which includes all construction materials and color additives.

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7. Non-clinical test performed on the proposed device:

The proposed device was tested and conformed to the following standards and requirements stated in guidance for industry passed and FDA Staff Surgical Masks – Premarket Notification [510(k)] Submission issued on March 5, 2004:

PerformanceCharacteristics	Test Method	Proposed device	Acceptance Criteria	Result
Fluid ResistancePerformance	ASTM F1862	31 out of 32 pass at120mmHg	29 out of 32 pass at120mmHg	Pass
Particulate FiltrationEfficiency	ASTM F2299	99.7%	≥ 98%	Pass
Bacterial FiltrationEfficiency	ASTM F2101	99.5%	≥ 98%	Pass
Differential Pressure(Delta-P)	MIL-M-36954C	4.24mmH2O/cm²	< 6.0mmH2O/cm²	Pass
Flammability class	16CFR 1610	Class 1	Class 1	Pass

Table 2 Performance Testing

8. Clinical test conclusion

No clinical study is included in this submission.

9. Conclusion

The conclusion drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicated K182515.

Regulation Number and Section

§ 878.4040 Surgical apparel.

(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.